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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLE - PHONE NUMBER AVAILABLE 200 West Zion Hill Road, Quakertown, PA 18951 SUMMARYCurrently coordinating and managing all startup activities associated with Clinical Trial study set ups. Demonstrating profound organizational skills to efficiently balance multiple projects while pushing them through development and testing in a timely manner. My interpersonal skills enable me to cultivate excellent working relationships, that at the end-of-the-day generate impactful results for all stakeholders.PROFESSIONAL EXPERIENCEJune 2019 to CurrentSetup Specialist II, ICON Clinical Research LLC Blue Bell, PA Clinical Laboratory Services DepartmentLead all clinical trial start-up activities and serve as the primary contact for Investigators and Research Coordinators in corporate sponsored human clinical trials.Accountable for accurately capturing all study information and specifications into a detailed document called a Client Laboratory Worksheet (CLW). This document enables execution of study designs, and encompasses the study protocol, sponsor request, ICON Laboratory standards/capabilities, and request/recommendations from internal operational groups.Manage and coordinate key internal/external stakeholder meetings to discuss study planning and execution details. Communicating information to other departments within ICON Laboratories to ensure a smooth study implementation.Train/mentor new Setup Specialist in setup processes to ensure study integrity and ICON standards are met.Serve as the subject matter expert for the sponsor in guiding them through a successful set up process by drawing on past experiences and standards. Highlighting any risks associated with the study to the sponsor and internal parties. Including participating in internal risk assessment and operational meetings as necessary.Delivering creative solutions and establishing best practices for laboratory set ups for new and complex protocol requirements.Independently manage laboratory set up timelines. Communicating major decisions or timeline changes during set up with the Laboratory Project Manager and other laboratory staff as necessary.Acquired an in-depth knowledge of Laboratory database and how amendments to the database affect different operational areas of laboratory. Efficiently anticipate and communicate these changes to all internal and external parties including sponsor, clinical and data management teams.October 2015 to June 2019Research Associate, EASi Contractor at Johnson & Johnson Medical Device Company - Somerville, NJBiocompatibility and Preclinical Toxicology Department Support preclinical activities related to all biocompatibility testing.Work side-by-side with Toxicologist/Biocompatibility Scientist to design and coordinate biocompatibility evaluations needed to yield relevant results for project teams, while in compliance with ISO 10993 standards, FDA regulations, GLP standards and regulatory authority requirements.Cross collaborates with various departments (chemistry, physiology, material science, engineering, performance, stability, marketing, manufacturing and packaging) at numerous project team meetings as a Toxicology Study Sponsors representative and biocompatibility liaison.Coordinate proper sample preparation and transfer, ensuring all testing material is manufactured properly (i.e.: build protocols, sterilization procedures, labeling, proper sizes) calculate quantities needed for testing requirements and ensure appropriate lots are transferred. Generating allforms needed to receive and transfer material to the CRO effectively, efficiently, and within compliance of departmental SOPs and GLP requirements.Effective communication with CRO making sure testing requirements are met, test samples are prepared properly and deadlines for studies are met. Including initiation and review of all study proposals, protocols, amendments, deviations and reports from a technical perspective, providing input and revision until final versions are approved. Lead, organize and maintain the Preclinical Biocompatibility Toxicology Study TrackerInitiated a new Toxicology tracker system to help organize and keep track of all toxicological support for the biocompatibility & toxicology team. Ensuring all pertinent information is collected to generate toxicology metrics that represents the teams efforts/workload for upper management meetings.Project lead and Owner for CAPA Gut Remediation ProjectCAPA owner for items that require Biocompatibility Study work. Fully trained on the EtQ CAPA systems and guidelines.Organize all preclinical activities for multiple projects within the CAPA initiative simultaneously ensuring timelines are met without any delay.Collected and generated Purchase Orders for studies and ensured funding was reflected and billed appropriately for the CAPA work, making sure the Budget Plan was on track. June 2002 October 2013Staff Biologist, Merck & Co., Inc., West Point, PA Neuroscience DepartmentProficiently supported the Neurochemistry efforts by managing and conducting all in vivo aspects of the Microdialysis lab.Coordinated/scheduled multiple project requests from various project teams, generating data that were pivotal turning points for the team in drug development.Mastered the art of scheduling/performing large magnitude of microdialysis surgeries and running multiple microdialysis studies simultaneously. Set up multiple microdialysis systems and training external CROs stereotactic surgeries to implant probes, enabling our department to double and triple their output capabilities. Implementation of NEW Assays and Surgical Capabilities.Enhanced lab productivity by setting up and validated new RATURN systems.Surgically implanted microdialysis probes into various brain regions in both rats and mice, using aseptic techniques.Manipulated standard microdialysis and surgical protocols for special applications, including: ICV infusion for drug delivery, and surgically implanting DUAL microdialysis probes for a drug delivery and CSF collection point.Trained, mentored and was a technical resource for: brain collection, CSF collection, histological probe placement, stereotactic surgeries and aseptic techniques, various methods of dosing and sample collection, and microdialysis skills and study work. Developed and validated new animal models to support Neuroscience research.IgG-192 cholinergic lesion model in Wistar Hanover and Sprague Dawley rats.Intraventricular Toxin Injections, under various forms of anesthesiaHarvested brains delicately for Immunohistochemistry processingConducted ChAT and standard ELISA assays.Scopolamine mouse model with a partial cognitive deficit.Detected deficit with behavioral assays and reversing it with compoundCollected cerebral spinal fluid and blood samples for PK analysisConducted and optimized the Contextual Fear Conditioning cognition assayPerform brain homogenizations, ELISAs and Genotyping Developmental and Reproductive Toxicology Department Developed technical skills needed for evaluating fetuses in skeletal, cardiac, internal/external examinations and reproductive abnormalities in a GLP lab.Drug PreparationRat, Mouse and Rabbit IP, IV, SC and oral dosingRat and Mouse CSF collectionRat, Mouse and Rabbit terminal and non-terminal blood collections, using various methods.Rat and rabbit C-sections and parental evaluationsOrganized and performed GLP studies in compliance with protocols & SOPs.Participated in internal audits for studies and data analysis/compiling. EDUCATIONBA, Neuroscience Major/Chemistry Minor; University of Delaware, Newark DE (2002) |
